Wednesday, 24 September 2025

North America

Olympus Initiates Global Removal of ViziShot 2 FLEX Needles Following Safety Reports

The voluntary action affects devices manufactured before May 12, 2025, after reports of component detachment linked to patient injuries and one death, with Olympus reinforcing safeguards to prioritise patient safety....

Shoulder Innovations Launches InSet™ 70 Humeral Stem to Expand I-Series Portfolio

The bone-sparing implant, cleared for both anatomic and reverse shoulder arthroplasty, enhances surgical flexibility and patient outcomes while reinforcing the company’s leadership in shoulder care innovation....

BD Partners with Henry Ford Health to Pioneer Automated Pharmacy of the Future

The collaboration introduces BD Rowa™ Vmax robotic technology to deliver 24/7 prescription access, streamline pharmacy operations, and empower staff to focus on patient-centred care....

QuidelOrtho Expands QUICKVUE Portfolio with FDA-Cleared Influenza + SARS Rapid Test

The new CLIA-waived immunoassay enables simultaneous detection of influenza A/B and SARS-CoV-2 in just 10 minutes, supporting faster, cost-effective decision-making at the point of care....

Techsomed Secures FDA 510(k) Clearance for BioTraceIO360 Kidney Ablation Indication

The expanded clearance extends BioTraceIO360 beyond liver applications to kidney procedures, advancing Techsomed’s vision of a multi-organ, AI-driven image-guided therapy platform that standardises minimally invasive cancer care....

Nicklaus Children’s Heart Institute Pioneers Bedside PDA Closures for Fragile Newborns Subheadline

The Institute, led by Dr. Shyam Sathanandam, is transforming neonatal cardiac care by delivering minimally invasive PDA closures directly in the NICU—eliminating transport risks and accelerating recovery for South Florida’s most vulnerable infants....

Medtronic secures FDA approval for Altaviva device

The Implantable Tibial Neuromodulation (ITNM) device will expand treatment options for the 16 million people living with urinary urges and involuntary leaks...

Argá Medtech Announces Enrollments in COHERENT-AF IDE Clinical Trial

The COHERENT-AF trial will enrol up to 360 patients across clinical sites in the United States and Europe...

Dornier MedTech America launches Hoover and AXIS II SLIM bar in kidney stone treatment

Together, the three devices streamline the procedure by combining effective stone treatment with rapid, controlled clearance...

ZKR Orthopaedics Announces First Patella LIFT Surgeries on the East Coast at Hospital

The outpatient procedures were performed as part of an ongoing FDA IDE clinical trial ...